Quality & Regulatory Graduate
Quality & Regulatory Graduate
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Salary Not Disclosed
1 Vacancy
Job Description
At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
The Position
As a Quality & Regulatory Graduate you will support Roche Dias compliance with ISO 13485 requirements and COREMAP documentation processes by assisting with ISO 13485 documentation from different departments maintaining quality and regulatory records with a focus on Fusion (DIA & DC) and LumiraDx supporting audits and ensuring regulatory requirements are met.
The Opportunity
- Assisting in documentation compliance and quality management system (QMS) processes.
- Maintaining and updating quality records supporting internal and external audits ensuring regulatory compliance and assisting in the implementation of quality procedures.
- Work closely with crossfunctional teams to ensure adherence to ISO 13485 standards contribute to process improvements and support risk management activities.
- Works crossfunctionally in the Network to review with the different teams the document retention period and identifies the country exceptions in the Global Records & Information Classification (GRIC).
- Builds the maintenance of record ownership into processes and supports record archiving and record inventories.
- Work crossfunctionally to ensure that the DC and LumiraDx regulatory and quality documents have been incorporated into the DIA folders and archiving system.
- Continuously assess and improve the quality management system to enhance efficiency and accuracy across all networks.
- Implement new technologies and best practices to enhance the quality management system across SAN.
Who you are
Qualifications & experience
Diploma or Degree in one of the following or related scientific disciplines: Pharmacy Pharmaceutical Chemistry Biology or Chemistry
Recommended skills & abilities
- Analytical thinking
- Accuracy and attention to detail
- Planning organizing and prioritizing
- Communication
- Problem solving
Who we are
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver lifechanging healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Employment Type
Full-Time
